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Emergency Use Authorization: Page 9
FDA airs antibody test performance specs, educational video
By
LabPulse.com staff writers
Many tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies have been introduced, some of which have received emergency use authorization (EUA) from the FDA. Recently, the FDA has tightened its policies and published a list of products that have been removed from eligibility to market.
June 4, 2020
Roche IL-6 test cleared, identifies high-risk COVID-19 patients
By
LabPulse.com staff writers
The emergency use authorization was granted on June 2 and Roche said that it is available for use on its cobas e analyzers, which are widely available globally. The test is available in countries that accept the CE Mark in addition to the U.S. The cobas analyzers offer throughput of 300 tests per hour and deliver results in approximately 18 minutes, according to the company.
June 3, 2020
FDA offers reference panel to help validate COVID-19 diagnostics
By
LabPulse.com staff writers
The reference panel is a tool for evaluating whether a diagnostic test is accurate in the detection of SARS-CoV-2 RNA. It will be available to commercial and laboratory developers pursuing clearance through the agency's emergency use authorization (EUA) program, the agency said in a May 27 announcement. Developers with well-characterized reagents will now be able to compare different tests under the same conditions, the agency said. Reference tools have been helpful for evaluating diagnostics for other infectious diseases in the past, such as the Zika virus.
May 27, 2020
FDA pulls plug on wayward coronavirus antibody tests
By
Emily Hayes
The names of the products and their manufacturers are now on a "removal list" as they are not in compliance with new regulatory requirements announced by the agency this month. It includes products that have been voluntarily withdrawn and products that have not been cleared through the FDA's emergency use authorization (EUA) pathway. Critics have been alarmed at what they saw as a lax regulatory approach during the pandemic, resulting in the market entry of many tests for immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies that had never been validated or reviewed. The agency responded by changing its policy to require commercial manufacturers to submit EUA requests within 10 business days from the date that they notified the agency of their validation testing. The FDA also now has specific performance thresholds that testing products must meet.
May 21, 2020
Pathnostics debuts COVID-19 PCR test
By
LabPulse.com staff writers
Pathnostics will perform its new test using Thermo Fisher Scientific's TaqPath reverse transcription (RT)-PCR COVID-19 kit, which received emergency use authorization from the U.S. Food and Drug Administration in March.
May 19, 2020
Roche's SARS-CoV-2 antibody test up and running at more than 20 U.S. labs
By
LabPulse.com staff writers
The company plans to make the test, which was granted an emergency use authorization from the U.S. Food and Drug Administration in May, available to more than 200 sites in the next several weeks. Labs will have the ability to perform more than 2Â million tests per week by June.
May 19, 2020
BioRad teams with Biodesix on COVID-19 total antibody test
By
LabPulse.com staff writers
The Platelia SARS-CoV-2 Total Ab test received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in late April. In clinical evaluation, the test yielded more than 99% specificity and 98% diagnostic sensitivity eight days after the onset of symptoms, according to the firms.
May 19, 2020
FDA updates guidance on coronavirus tests
By
LabPulse.com staff writers
The guidance document sets policy for test standards on an emergency basis; it takes effect immediately, though the agency is accepting comments from stakeholders. Guidance on the agency's policies for COVID-19 testing was initially published on February 29 and has now been revised three times.
May 14, 2020
FDA-authorized antibody tests fall short in comparative study
By
Emily Hayes
The researchers evaluated the Abbott Architect i200 SARS-CoV-2 immunoglobulin G (IgG) test and the Euroimmun EI Anti-SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) IgG test in 103 specimens from 48 patients who had been diagnosed with COVID-19 with polymerase chain reaction (PCR) technology and 153 control specimens. Both tests have emergency use authorizations (EUAs) from the U.S. Food and Drug Administration (FDA).
May 14, 2020
Fluxergy invests $30M to produce more point-of-care SARS-CoV-2 tests
By
LabPulse.com staff writers
The Fluxergy Analyzer test system, which uses polymerase chain reaction (PCR) and microfluidics technology, identified the SARS-CoV-2 virus in less than one hour during bench lab validation studies conducted by the company and in an analysis of patient samples conducted by scientists at the University of California, San Diego (UCSD).
May 12, 2020
Thermo Fisher, WuXi, Mayo Clinic to develop COVID-19 test
By
LabPulse.com staff writers
The company's OmniPath COVID-19 Total Antibody enzyme-linked immunosorbent assay (ELISA) test will detect immunoglobulin M (IgM) and immunoglobulin G (IgG), helping clinicians to determine whether a patient has been exposed to SARS-CoV-2. The test will be designed to run on an open instrument platform. In the next few weeks, Thermo Fisher will seek an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) and authorizations from other international regulatory agencies for the test.
May 12, 2020
Ortho wins CE Mark for COVID-19 total antibody test, partners with Quest
By
LabPulse.com staff writers
Ortho's total antibody test detects all COVID-19 related antibodies -- immunoglobulin M (IgM), immunoglobulin G (IgG), and immunoglobulin A (IgA). It runs on Ortho's flagship Vitros XT 7600 integrated system, Vitros 3600 immunodiagnostic, and Vitros 5600 integrated systems. The test will also soon be available on the Vitros ECi/ECiQ immunodiagnostic systems.
May 12, 2020
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